Tag Archives: Regulation

I’m not particularly concerned about this new invention from a gun control standpoint; people with physical disabilities come in all political stripes, and many may feel that they need firearms in order to avoid becoming easy targets for violence. But why, again, does the FDA need to list it as a medical device? According to an FDA employee:

“This allows someone to do something that a normal person can do. It allows them to overcome some disability to act in a more normal way.”

The FDA’s definition of “medical device” includes instruments “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.” This is the only part of the definition that could conceivably cover this handgun.

In some sense, the gun does “mitigate” a disease that causes disability, as could any everyday tool that’s adapted to be used by people with disabilities. But the same is true of large-print textbooks, Kurzweil machines, segways, and my voice recognition software. At what point does a product that is usable by people with disabilities become a “medical device”?

If the FDA begins to assert broader authority to regulate everyday products that have adaptive features, it could have a deterrent effect on companies interested in developing them. Why take the time to make a handgun that is regulated by both the FDA and the Bureau of Alcohol, Tobacco, and Firearms and that has a very limited target market, when you can just continue focusing on handguns that are only regulated by ATF?